Hypothesis:The addition of repeated sharp scalpel debridement of callus to a long-term care plan offers no greater reduction in pain or improvement in functional status than a low-risk, long-term care plan based on conservative self care, footwear advice, padding and/orthoses.

Ethics approval

Ethics approval received from the Leeds (West) Research Ethics Committee on the 30th May 2007 (ref: 07/Q1205/70).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Rheumatoid arthritis

Intervention

Conservative long-term therapies:Usual conservative long-term therapies will be provided to patients in both the treatment and control arms. Long-term therapies include education and self-management advice, footwear advice, prescription of foot orthoses, referral for orthopaedic footwear, referral to physiotherapy, and intra-articular and soft tissue injection therapy. Patients in the control arm will receive the long-term therapeutic protocol only, while patients in the treatment arm will receive the long-term therapeutic protocol plus sharp scalpel debridement of callosities.

Callus debridement:Patients in the treatment arm will receive repeat callus debridement in addition to the standard long-term therapy. Debridement will involve regular removal of the callused lesions with a scalpel. The intervals between debridement will be determined by the clinician according to a debridement protocol, and may be altered during the course of the study dependent upon the requirements of the individual patient.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measure

Forefoot pain measured by 100 mm Visual Analogue Scale (VAS) and the pain subscale of the Foot Function Index (FFI). Patients in both treatment arms will complete pain scores at 6, 12 and 18 weeks (± 2 weeks); and at 6, 9, 12 and 18 months (± 1 month). The Leeds Foot Impact Scale (LFIS) will be used to measure the impact of foot pain, impairment, activity limitation and footwear at baseline, 6 and 12 months and at exit (18 months).

Overall trial start date

Overall trial end date

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Positive diagnosis of RA (American Rheumatology Association [ARA]/American College of Rheumatology [ACR] classification 1987) 2. One or more painful forefoot plantar callosities (including corns) 3. Willingness to participate in trial for 18 months 4. Participants aged more than or equal to 16, male and female

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

64

Participant exclusion criteria

1. Co-morbidity which would place the patient at risk if randomised to the control arm, e.g. diabetes mellitus, peripheral arterial insufficiency, loss of protective sensation, existing risk/presence of ulceration/extravasation at baseline 2. History of routine podiatric intervention including callus debridement on two or more occasions in the previous 12 months

Recruitment start date

15/10/2007

Recruitment end date

15/10/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
Leeds
LS2 9NZ
United Kingdom

Sponsor information

Organisation

Leeds Teaching Hospital NHS Trust (UK)

Sponsor details

Research Development Office Floor A/B Old Site Great George Street Leeds LS1 3EX United Kingdom
+44 (0)113 392 2878derek.norfolk@leedsth.nhs.uk